Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2026-03-15 @ 8:19 PM
Study NCT ID:
NCT04250727
Status:
COMPLETED
Last Update Posted:
2024-05-01
First Post:
2020-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Switching to Potential Reduced Exposure Products in Adult Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D040261', 'term': 'Harm Reduction'}, {'id': 'D063646', 'term': 'Carcinogenesis'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lisa.fucito@yale.edu', 'phone': '(203) 688-1878', 'title': 'Lisa Fucito, PhD: Associate Professor of Psychiatry; Director, Tobacco Treatment Service, Psychiatry', 'organization': 'Yale School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 4 weeks', 'eventGroups': [{'id': 'EG000', 'title': '3mg Nicotine Concentration', 'description': '15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration.\n\nZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 13, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '6mg Nicotine Concentration', 'description': '15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration.\n\nZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 13, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'rapid heartbeat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'vision problems', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'appetite changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'fainting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'vivid dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'difficulty sleeping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'coughing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'itching or rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'sweating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Cigarettes Smoked Per Day (Log-transformed)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3mg Nicotine Concentration', 'description': '15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration.\n\nZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.'}, {'id': 'OG001', 'title': '6mg Nicotine Concentration', 'description': '15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration.\n\nZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to week 4', 'description': 'The investigators will compare whether smoking behavior varies by the 3mg and 6mg nicotine concentrations as measure by the standardized Timeline Followback Interview.', 'unitOfMeasure': 'number of cigarettes smoked', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Switched From Cigarettes to the ZYN Pouches.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3mg Nicotine Concentration', 'description': '15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration.\n\nZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.'}, {'id': 'OG001', 'title': '6mg Nicotine Concentration', 'description': '15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration.\n\nZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'This will be evaluated at week 4.', 'description': 'To investigate whether switching behavior varies by the 3mg and 6mg nicotine concentrations', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Smoke Free Days.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3mg Nicotine Concentration', 'description': '15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration.\n\nZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.'}, {'id': 'OG001', 'title': '6mg Nicotine Concentration', 'description': '15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration.\n\nZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.57', 'spread': '22.42', 'groupId': 'OG000'}, {'value': '11.22', 'spread': '24.58', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.601', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'up to week 4', 'description': 'The investigators will compare whether the smoke free days vary by the 3mg and 6mg nicotine concentrations', 'unitOfMeasure': 'percentage of smoke free days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Level of Biomarker (NNAL) Among Smokers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3mg Nicotine Concentration', 'description': '15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration.\n\nZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.'}, {'id': 'OG001', 'title': '6mg Nicotine Concentration', 'description': '15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration.\n\nZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '17.26', 'spread': '1.89', 'groupId': 'OG000'}, {'value': '15.98', 'spread': '1.89', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '18.55', 'spread': '1.94', 'groupId': 'OG000'}, {'value': '16.04', 'spread': '1.91', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and week 4', 'description': 'Participants will provide repeated lab samples for biomarker assessments. Urine samples obtained will be compared at baseline and week 4 for differences by group and by time.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Effects of Oral Nicotine Pouches', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3mg Nicotine Concentration', 'description': '15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration.\n\nZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.'}, {'id': 'OG001', 'title': '6mg Nicotine Concentration', 'description': '15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration.\n\nZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.'}], 'timeFrame': 'week 4', 'description': 'To evaluate the acceptability of switching, participants will also be asked how likely it is that they will continue to use ZYN oral nicotine patches for cigarette substitution compared to cigarettes on a question designed for this trial.', 'reportingStatus': 'POSTED', 'populationDescription': 'This measure was not used in the study and therefore data were not collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '3mg Nicotine Concentration', 'description': '15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration.\n\nZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.'}, {'id': 'FG001', 'title': '6mg Nicotine Concentration', 'description': '15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration.\n\nZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '3mg Nicotine Concentration', 'description': '15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration.\n\nZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.'}, {'id': 'BG001', 'title': '6mg Nicotine Concentration', 'description': '15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration.\n\nZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.20', 'spread': '9.70', 'groupId': 'BG000'}, {'value': '55.47', 'spread': '13.40', 'groupId': 'BG001'}, {'value': '56.83', 'spread': '11.60', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race Customized', 'categories': [{'title': 'Black/African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'White/Caucasian', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Smoke within 30 minutes of waking', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'This is binary count of yes/no responses to whether or not participants smoke their first cigarette within 30 minutes of waking in the morning.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-28', 'size': 472033, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-14T16:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '30 current non-treatment seeking adult smokers will be randomized to either the 3mg or 6mg nicotine concentration ZYN condition.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'dispFirstSubmitDate': '2023-08-15', 'completionDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-30', 'studyFirstSubmitDate': '2020-01-17', 'resultsFirstSubmitDate': '2023-10-31', 'studyFirstSubmitQcDate': '2020-01-29', 'dispFirstPostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-27', 'studyFirstPostDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Cigarettes Smoked Per Day (Log-transformed)', 'timeFrame': 'up to week 4', 'description': 'The investigators will compare whether smoking behavior varies by the 3mg and 6mg nicotine concentrations as measure by the standardized Timeline Followback Interview.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Switched From Cigarettes to the ZYN Pouches.', 'timeFrame': 'This will be evaluated at week 4.', 'description': 'To investigate whether switching behavior varies by the 3mg and 6mg nicotine concentrations'}, {'measure': 'Percentage of Smoke Free Days.', 'timeFrame': 'up to week 4', 'description': 'The investigators will compare whether the smoke free days vary by the 3mg and 6mg nicotine concentrations'}, {'measure': 'Level of Biomarker (NNAL) Among Smokers', 'timeFrame': 'baseline and week 4', 'description': 'Participants will provide repeated lab samples for biomarker assessments. Urine samples obtained will be compared at baseline and week 4 for differences by group and by time.'}, {'measure': 'Subjective Effects of Oral Nicotine Pouches', 'timeFrame': 'week 4', 'description': 'To evaluate the acceptability of switching, participants will also be asked how likely it is that they will continue to use ZYN oral nicotine patches for cigarette substitution compared to cigarettes on a question designed for this trial.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Tobacco Use Disorder', 'Oral Nicotine Pouch Use', 'Smoking Behaviors', 'Harm Reduction', 'Toxic Effect of Tobacco and Nicotine', 'Carcinogenesis']}, 'referencesModule': {'references': [{'pmid': '24951496', 'type': 'BACKGROUND', 'citation': "Berg CJ, Haardoerfer R, Escoffery C, Zheng P, Kegler M. Cigarette users' interest in using or switching to electronic nicotine delivery systems for smokeless tobacco for harm reduction, cessation, or novelty: a cross-sectional survey of US adults. Nicotine Tob Res. 2015 Feb;17(2):245-55. doi: 10.1093/ntr/ntu103. Epub 2014 Jun 20."}, {'pmid': '24249254', 'type': 'BACKGROUND', 'citation': "Brawley OW, Glynn TJ, Khuri FR, Wender RC, Seffrin JR. The first Surgeon General's report on smoking and health: the 50th anniversary. CA Cancer J Clin. 2014 Jan-Feb;64(1):5-8. doi: 10.3322/caac.21210. Epub 2013 Nov 18. No abstract available."}, {'pmid': '24962838', 'type': 'BACKGROUND', 'citation': 'Brenner DR, Scherer D, Muir K, Schildkraut J, Boffetta P, Spitz MR, Le Marchand L, Chan AT, Goode EL, Ulrich CM, Hung RJ. A review of the application of inflammatory biomarkers in epidemiologic cancer research. Cancer Epidemiol Biomarkers Prev. 2014 Sep;23(9):1729-51. doi: 10.1158/1055-9965.EPI-14-0064. Epub 2014 Jun 24.'}, {'pmid': '16875787', 'type': 'BACKGROUND', 'citation': 'Cappelleri JC, Bushmakin AG, Baker CL, Merikle E, Olufade AO, Gilbert DG. Confirmatory factor analyses and reliability of the modified cigarette evaluation questionnaire. Addict Behav. 2007 May;32(5):912-23. doi: 10.1016/j.addbeh.2006.06.028. Epub 2006 Jul 27.'}, {'pmid': '26939927', 'type': 'BACKGROUND', 'citation': 'Cella D, Lai JS, Jensen SE, Christodoulou C, Junghaenel DU, Reeve BB, Stone AA. PROMIS Fatigue Item Bank had Clinical Validity across Diverse Chronic Conditions. J Clin Epidemiol. 2016 May;73:128-34. doi: 10.1016/j.jclinepi.2015.08.037. Epub 2016 Mar 3.'}, {'pmid': '28151705', 'type': 'BACKGROUND', 'citation': 'Chang CM, Edwards SH, Arab A, Del Valle-Pinero AY, Yang L, Hatsukami DK. Biomarkers of Tobacco Exposure: Summary of an FDA-Sponsored Public Workshop. Cancer Epidemiol Biomarkers Prev. 2017 Mar;26(3):291-302. doi: 10.1158/1055-9965.EPI-16-0675. Epub 2016 Nov 9.'}, {'pmid': '29346338', 'type': 'BACKGROUND', 'citation': 'Jamal A, Phillips E, Gentzke AS, Homa DM, Babb SD, King BA, Neff LJ. Current Cigarette Smoking Among Adults - United States, 2016. MMWR Morb Mortal Wkly Rep. 2018 Jan 19;67(2):53-59. doi: 10.15585/mmwr.mm6702a1.'}, {'pmid': '11260806', 'type': 'BACKGROUND', 'citation': 'Cox LS, Tiffany ST, Christen AG. Evaluation of the brief questionnaire of smoking urges (QSU-brief) in laboratory and clinical settings. Nicotine Tob Res. 2001 Feb;3(1):7-16. doi: 10.1080/14622200020032051.'}, {'pmid': '26525063', 'type': 'BACKGROUND', 'citation': 'Delnevo CD, Giovenco DP, Steinberg MB, Villanti AC, Pearson JL, Niaura RS, Abrams DB. Patterns of Electronic Cigarette Use Among Adults in the United States. Nicotine Tob Res. 2016 May;18(5):715-9. doi: 10.1093/ntr/ntv237. Epub 2015 Nov 2.'}, {'pmid': '15824536', 'type': 'BACKGROUND', 'citation': 'Fagerstrom KO. 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(pp. 75-99). Bethesda, MD: National Institute on Alcohol Abuse & Alcoholism.'}, {'pmid': '28860576', 'type': 'BACKGROUND', 'citation': 'Zhang M, Li G, Wang Y, Wang Y, Zhao S, Haihong P, Zhao H, Wang Y. PD-L1 expression in lung cancer and its correlation with driver mutations: a meta-analysis. Sci Rep. 2017 Aug 31;7(1):10255. doi: 10.1038/s41598-017-10925-7.'}, {'pmid': '40550628', 'type': 'DERIVED', 'citation': "Fucito LM, Baldassarri SR, Wu R, Gueorguieva R, Morean ME, Herbst RS, Krishnan-Sarin S, O'Malley SS. Effects of oral nicotine pouches on cigarette smoking behaviour and tobacco harm exposure: a randomised pilot trial in adults. Tob Control. 2025 Jun 23:tc-2024-059094. doi: 10.1136/tc-2024-059094. Online ahead of print."}]}, 'descriptionModule': {'briefSummary': 'This study aims to assess the feasibility, acceptability, and the potential harm reduction of switching to potentially lower risk, oral nicotine pouches in adult smokers. Part One of this study aims to assess the interest of current smokers in switching to an e-cigarette device (i.e. JUUL) compared to alternative non-combustible tobacco products (i.e. smokeless tobacco/snus) and/or medicinal nicotine via survey. Part Two will consist of a pilot study of 30 non-treatment seeking adult smokers to investigate within-person changes in smoking behavior as a result of switching to different concentrations of oral nicotine pouch products (i.e. ZYN, 3mg and 6mg nicotine concentration). Additionally, by measuring bio-markers of tobacco exposure from baseline, this will allow the study to assess the potential for harm reduction in switching from cigarettes to oral nicotine pouches.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '77 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 21-77 years old(in line with NIH guidelines for 18+ being the age of consent in adults) (2008 PHS Guideline Update Panel)\n2. English literate\n3. Smoke at least 1 cigarette per day\n4. Expired breath carbon monoxide level ≥ 6ppm at baseline\n5. Not currently actively pursuing smoking cessation services or planning to use evidence-based cessation tools to quit in the next month\n6. Not interested in the use of existing FDA-approved tobacco pharmacotherapies (i.e., NRT, wellbutrin, varenicline).\n\nExclusion Criteria:\n\n1. Currently using any stop smoking treatments (2008 PHS Guideline Update Panel)\n2. History of serious psychiatric condition (i.e., bipolar disorder, schizophrenia)\n3. Current uncontrolled medical condition\n4. Cardiac conditions that required a hospitalization or intensive treatment on an outpatient basis in the past year including: myocardial infarction, coronary artery disease, unstable angina, congestive heart failure, or tachyarrhythmias (including rapid atrial fibrillation, ventricular tachycardia, or ventricular fibrillation)\n5. Female participants of child-bearing age will be excluded if they are currently pregnant or breastfeeding or report an unwillingness to use effective birth control (i.e., abstinence, IUD, implant, sterilization, pill, patch, ring, or barrier method such as condoms) for the duration of the study\n6. Severe lung disease that requires supplemental oxygen\n7. Uncontrolled asthma (\\<20 on the Asthma Control Test (ACT) or requiring steroids more than 1x per year)\n8. Unstable COPD: defined as GOLD category C or D (more than 2 exacerbations or 1 exacerbation leading to hospitalization in the past year)\n9. Planning to quit smoking with a set goal or time for quit attempt\n10. Known hypersensitivity to propylene glycol\n11. Patients with an FEV1 \\< 40%'}, 'identificationModule': {'nctId': 'NCT04250727', 'acronym': 'ZYN', 'briefTitle': 'Switching to Potential Reduced Exposure Products in Adult Smokers', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Switching to a Non-tobacco-based Oral Nicotine Product Among Adult Cigarette Smokers: Exploring the Roles of Product Characteristics and User History', 'orgStudyIdInfo': {'id': '2000023826'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3mg Nicotine Concentration', 'description': '15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration.', 'interventionNames': ['Device: ZYN']}, {'type': 'EXPERIMENTAL', 'label': '6mg Nicotine Concentration', 'description': '15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration.', 'interventionNames': ['Device: ZYN']}], 'interventions': [{'name': 'ZYN', 'type': 'DEVICE', 'description': '30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.', 'armGroupLabels': ['3mg Nicotine Concentration', '6mg Nicotine Concentration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}